Category: allergy drugs

On June 19, 2006, Novartis Consumer Health issued a recall for the cough-suppressing Triaminic Vapor Patches in the US, about three weeks after Health Canada issued a warning after a Canadian child who chewed on a patch suffered a seizure.

There have been eight adverse events with the patch, all involving ingestion, Navartis spokesperson, Julie Masow, told the Philadelphia Inquirer on June 21, 2006.

The patches were sold over the counter at pharmacies and retail stores and Novartis said it has sold more than 50 million vapor patches since they came on the market in 2000.

The Swiss drug maker warned consumers to stop using the patch immediately and said they should either be discarded or returned to the place of purchase for a full refund.

The patches contain camphor, eucalyptus oil and menthol and are meant to be applied to the chest or throat of children as young as 2 years-old. Novartis said the placement of the patch can allow children to remove them and place them in their mouths. It is difficult to believe that the idea never occurred to the drug maker that a 2 year-old would attempt to pick the cherry-scented patch off and eat it.

Ingesting camphor or eucalyptus oils can cause a burning sensation in the mouth, nausea, headache, vomiting and seizure. Other complaints received by the company associated with the patch include reports of blistering, bruising, scarring, hyperactivity and depigmentation.

Whether the patch will remain off the market is not known. According to a June 21, 2006, Press Release by the LecTec Corporation, in January 2004, LecTec entered into a Supply and License Agreement with Novartis under which LecTec licensed certain of its patents to Novartis for the production of vapor patches.

In response to a question from LecTec, a representative of Novartis indicated that no decision had been made whether to reintroduce the product in certain markets, although the patches would definitely not be reintroduced for use by young children, the press release said.

The royalties received by LecTec under this agreement represented substantially all of the firm’s revenues in fiscal 2005, as well as the first quarter of fiscal 2006. The specific patch that caused the seizure was not manufactured by LecTec, according to Novaris quoted in the press release.

Over roughly the past 25 years, patch medications have become a booming business for Big Pharma. More than 30 different types of patches have been used by 12 million people worldwide for conditions ranging from birth control to heart disease to chronic pain to bladder control. The first antidepressant patch was approved by the FDA this month.

In 2004, patch sales totaled about $3.4 billion, according to the medical market research firm Greystone Associates.

All medication releasing patches work the same, according to Bozena Michniak, who studies transdermal patch delivery systems at the Center for Biomaterials at Rutgers University. The medication seeps through the skin into the bloodstream, and the increased blood flow causes the body to absorb the drug.

As more versions of the medication patches are introduced on the market, medical experts say that many of them are unsafe. Multiple studies have shown that heat has a dangerous effect on the patches, whether from a high fever, exercise or a hot tub. Heat increases the absorption rate of the medication and sometimes with fatal results.

As far back as 1986, a study found that just 20 minutes of bicycling with a nitroglycerin patch increased concentration of the drug two to threefold. Similar results were found after 30 minutes in a sauna, according to an article in Philly.com on March 5, 2006.

But yet there was no public warnings added to the Fentanyl pain patch until 36-year-old Kurt Hophan died in Pennsylvania on March 4, 1994.

Fentanyl, a schedule II narcotic analgesic, is roughly 50-80 times more potent than morphine and is used to manage both pain during surgery and for persons with chronic moderate to severe pain who already are physically tolerant to opiates, according to the US Center for Substance Abuse Treatment.

Mr Hophan applied the patch for pain relief associated with a back injury and went to his bedroom in his mother’s home and fell asleep with a heating pad and an electric blanket.

When the heat from the pad and the blanket came into contact with the patch, the amount of Fentanyl released into Mr Hophan’s bloodstream was estimated to be about 100 times greater than the amount prescribed, according to a judge’s opinion in a lawsuit filed by Mr Hophan’s mother, Elaine Hophan, against the drug’s maker.

In 2001, a jury awarded Ms Hophan $5 million in damages but after an appeal, the case was settled under a confidential settlement agreement.

Fentanyl patches are sold under a variety of brand and generic names. Johnson and Johnson’s Duragesic was the first on the market arriving in the early 1990s. It’s the most popular patch with four million prescriptions filled at US pharmacies last year.

Worldwide sales of Duragesic in 2005 were $1.59 billion, according to J& J’s earnings reports. The cost of a 30-day supply ranges from $348 at Target to $408 at Wal-Mart, according to FDA documents.

On April 5, 2004, J&J issued a recall for defective patches that applied to specific lots of patches, which had a faulty seal that permitted Fentanyl to seep from the patch, resulting in patients being given an overdose of Fentanyl.

On July 15, 2005, the FDA issued a public health advisory about the proper way to use the Fentanyl patches to avoid overdose, in response to reports of deaths in patients using the narcotic patch for pain management.

The Los Angeles County Coroners Office reports a growing number of accidental over-doses by patients misusing the patch: 127 deaths over the last six years, according to a CBS News report on December 20, 2005.

“They’re not getting the relief that they want. Therefore they’re slapping more patches on trying to get that instantaneous relief,” says toxicologist Daniel Anderson. “What they don’t realize is that most of these patches are to be applied over a three-day period.”

Utah statistics according to the latest mortality data from the state Health Department show Fentanyl was related to 29 accidental deaths in 2005, up from nine in 2004, and 13 in 2002, according to the March 14, 2006 Salt Lake Tribune.

Lawsuit are being filed as a result of the high accidental overdose rate. Robert Debry & Associates, in Salt Lake City has taken about a dozen cases involving deaths allegedly from Fentanyl. One lawsuit is filed on behalf of the family of Marilyn Titus who died December 14, 2003, at age 72 and alleges Ms Titus, was suffering from severe back pain, and was sold defective and leaking patches.

In December 2005, surviving family members of two more Utah women filed wrongful death lawsuits, alleging the patches leaked and caused the deaths of both women.

Autopsy reports said the women died from drug poisoning after using pain patches. Both lawsuits claim the women were prescribed the patch and were found dead in their homes within one or two days of using the patch.

Both lawsuits claim negligence for failing to research and design the patch and allege the companies misrepresented the safety of the patch for human use.

Overall, US emergency room doctors saw overdoses of Fentanyl grow from 28 in 1994 to 1,506 in 2002, according to the most recent statistics available from the US Substance Abuse and Mental Health Administration.

In March 2006, the FDA announced it would conduct a review of all medication patches beginning with Fentanyl and the Ortho Evra birth control patch, also made by J& J.

The following month, an April 10, 2006, Long Island Newsday report said that “hundreds” of women had filed lawsuits against Ortho-McNeil, the J&J division that manufactures the Ortho Evra patch.

And there will no doubt be many more filed against the company because in 2005, doctors wrote more than 9.4 million prescriptions for the birth control patch, according to IMS Health, an pharmaceutical industry monitoring firm.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra Patch.

In the new warning, Ortho McNeil admits for the first time that women who use the patch are exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. It is widely understood that any increase in the exposure to estrogen also increases the risk of blood clots.

A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.

Around the time the company introduced the patch to the market, the lawsuit claims, Ortho’s patent for its contraceptive pill, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue.

In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, that showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth control pills.

The news segment also revealed that during the same time frame, 4 times as many strokes occurred in women using the patch when compared to women using the pill, even though 3 times more women were taking the pill. Overall, in medically confirmed cases, the risk of blood clots was found to be 14 times more likely to occur in women using with the patch.

Since the FDA only receives reports for between 1% and 10% of the serious adverse drug events, the actual death and injury rate for women on the patch is estimated to be much higher that the number of reports registered so far with the FDA

The Ortho Evra Patch was approved by the FDA in November 2001. Over 4 million women have reportedly used the patch since its approval and it remain on the market today.

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The requirement for a more prominent warning regarding an increased risk of neuropsyhiatric events, including suicide, applies to Singulair (montelukast), and Accolate (zafirlukast), leukotriene receptor antagonists, and Zyflo and Zyflo CR (zileuton), a leukotriene synthesis inhibitor.

The reported neuropsychiatric events “include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor,” the FDA said in a June 12, 2009, statement on its Website.

“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” the FDA states.

“FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling),” the agency notes.

Singulair, Accolate, and Zyflo are approved to treat asthma, and Singulair is also approved to treat allergic rhinitis and prevent exercise induced asthma.

In March 2008, the FDA announced that Singulair may be associated with suicidality and suicide, and subsequently conducted a review of neuropsychiatric events in post marketing reports and clinical trial data submitted by the drug makers.

Events were not found to be common in the clinical trials but the trials were not designed to look for neuropsychiatric events, the FDA said. “Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo,” the agency noted.

AstraZeneca markets Accolate, and Zyflo is made by Cornerstone Therapeutics. Singulair was Merck’s top selling product in 2008, and the sixth top selling drug in the US, with sales of $3.5 billion, according a March 2009 report by IMS Health.